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The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.
A robotic exercise device has been developed(MIT-MANUS)capable of providing therapy to the arm for patients with weakness due to stroke. The randomized trial will compare conventional care, planar robot intervention and an intervention of planar and vertical robot training among patients with chronic, stable deficits. We will evaluate motor outcomes, effectiveness, cost, patient satisfaction and quality of life. The study will determine the efficacy of upper extremity robot therapy compared to supervised self-administered exercise therapy in patients with deficits due to stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Robot Exercise Group |
|
| Arm 2 | Active Comparator | Traditional Upper Extremity Exercise Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Upper Extremity Neurorehabilitation | Device | Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot |
|
| Measure | Description | Time Frame |
|---|---|---|
| Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002). Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome. | Baseline to Final Training (6 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Bever, MD | VA Maryland Health Care System, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Maryland Health Care System, Baltimore | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21849168 | Result | Conroy SS, Whitall J, Dipietro L, Jones-Lush LM, Zhan M, Finley MA, Wittenberg GF, Krebs HI, Bever CT. Effect of gravity on robot-assisted motor training after chronic stroke: a randomized trial. Arch Phys Med Rehabil. 2011 Nov;92(11):1754-61. doi: 10.1016/j.apmr.2011.06.016. Epub 2011 Aug 17. |
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Participants were excluded prior to randomization if they did not meet inclusion/exclusion criteria. Some candidates declined after learning of the study length and schedule committment.
147 community-dwelling adults with a diagnosis of chronic stroke were referred for study criteria screening by local VA stroke clinics and PT/OT clinicians. Community study advertisements and flyers were also utulized during this recruitment period that started October 2006 and ended December 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Planar Robot | Robot-assisted planar reaching x 60 minutes |
| FG001 | Planar + Vertical Robot | Robot-assisted planar and robot-assisted vertical reaching x 60 minutes |
| FG002 | Intensive Conventional Exercise | Upper extremity stretching, skateboard reaching activites, range of motion and arm ergometer x 60 minutes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Planar Robot | Robot-assisted planar reaching x 60 minutes. |
| BG001 | Planar + Vertical Robot | Robot-assisted planar and robot-assisted vertical reaching x 60 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002). Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome. | The number of participants analyzed were based on an intention to treat methodology with the exception of individuals that were non-compliant with the protocol or did not progress to the midpoint (3 week) evaluation. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Final Training (6 weeks) |
Adverse event data was collected over a 6 month time period for each participant which included baseline testing, intervention and retention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Planar Robot | Planar Robot Exercise Group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Non-systematic Assessment | One participant experienced non-study related renal failure. One participant experienced non-study related medical status change. One participant experienced non-study related hip fracture after fall at home. |
This study was terminated early with the current number of subjects analyzed. A midstudy futility analysis showed a need for 99 participants per group to determine signifcance between the robotic training over the intensive conventional exercise.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan S. Conroy | VA Maryland Health Care System, Baltimore | (410) 605-7000 | 3213 | susan.conroy@va.gov |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Traditional Upper Extremity Exercise Group | Other | Upper extremity stretching, skateboard reaching activities, and arm ergometer |
|
| Withdrawal by Subject |
|
| BG002 | Intensive Conventional Exercise | Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fugl-Meyer Upper Extremity Motor Assessment | The upper extremity portion of the Fugl-Meyer Motor Assessment has a range of 0 to 66 with 0 being the minimum score and 66 the maximum. A higher score indicates a better outcome. | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|
| OG000 | Planar Robot | Planar Robot Exercise x 60 minutes. |
| OG001 | Planar + Vertical | Planar + Vertical Robot Exercise x 60 minutes. |
| OG002 | Intensive Conventional Exercise | Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes. |
|
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | Planar + Vertical Robot | Planar + Vertical Robot Exercise Group | 0 | 21 | 1 | 21 |
| EG002 | Intensive Conventional Exercise | Upper extremity stretching, skateboard reaching activities, range of motion and arm ergometer training. | 0 | 21 | 1 | 21 |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | One participant with shouler pain in the study arm limiting participation in traditional upper extremity exercise. |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |